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Vaccine Innovation Conference

Toronto, May 26, 2015

Formulations, Delivery and Bioprocessing

Jim Richards, National Research Council of Canada

Vaccine Formulation, Delivery and Bioprocessing – a Look at the

Canadian Landscape

Adjuvants

Dose Sparing

Thermostable

Cancer

(CMI)Robust

Immunity

Immuno-compromised

Needle-free

Formulation and Delivery

New formations leading to challenges in vaccine

development and manufacture…

Modern Vaccines – with the use of novel compounds and

formulation technologies - are complex and difficult to test

Require additional scrutiny and validation which can slow

vaccine development due to significant challenges in

vaccine regulation

Formulation stability is a key consideration for vaccine

manufactures – formulations need to be tailored for use in

a cGMP environment

Vaccine Manufacturing in Canada

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GSK Vaccines

St Foy PQ

Influenza Manufacture

Sanofi Pasteur

Connaught Campus, Toronto ON

R&D and Manufacturing

Pilot facility

cGMP material for clinical trials

Manufacturing facilities

Canada (Quebec City)

USA (North Carolina)

Commercial facility

• cGMP large scale

• Pandemic, seasonal flu

Medicago – Plant Manufacturing facilities

What about the ~40 Canadian SME Product

Developers

Contract Organizations:CRO Preclinical Contract Research OrganizationsCMO Contract Manufacturing OrganizationsCTO Clinical Trial Organizations

Milestones:IND Investigational New Drug (tests in humans)NDA National Drug Application (market)

Preclinicalstudies

Toxicology

CROMicrobialcGMPproduction

MammaliancGMPproduction

CMO Liquid vials

Lyophilizing

Fill FinishRecruiting patients

Conducting tests

Data collection

CTOMarketing

Sales

Distribution

Surveillance

Market

Consultant IND

Consultant NDA

SME

What happens after development?

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Vaccines and biologics production in mammalian cells includes:

• Development of cell lines, media and components

• Pilot to production scale-up in bioreactors and fermenters

• Purification

• cGMP production scale-up for clinical useUnfortunately, production for clinical use is currently outsourced

to Contract Manufacturing Organizations (CMOs) outside Canada (mainly US), resulting in a loss of economic impacts for

Canada.

Canadian CMOs – Current Status

NRC Biomanufacturing Initiative – Fostering Strong,

Prosperous Canadian Biomanufacturing Sector

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• Transferring NRC expression systems and bioprocessing know-how to Canadian CMOs producing cGMP-quality material in mammalian cellexpression systems

CHO cells HEK293 cells

• Encouraging SME developers to select Canadian CMOs to produce their biologics and vaccines for clinical trials and market

NRC Mammalian cell pilot plant up to 500 L

Todays Session

Dr. Denis Leclerc (Folia Biotech): A novel Canadian adjuvant

and its potential in vaccine development and immunotherapy

Dr. Volker Gerdts (VIDO-InterVac): Innovations that have led to

the development of improved vaccine formulations and

delivery strategies, and which are currently being evaluated in

the preclinical stage.

Dr. S. Fernando Ausar (Sanofi Pasteur): Essential steps

required for optimal formulation development of vaccines and

the recent technological advances in formulation sciences.